In Lance v. Wyeth, --- A.3d ---, 2014 WL 260309 (Pa. Jan. 21, 2014), the Pennsylvania Supreme Court ruled that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs.
In Lance, plaintiff alleged that her daughter’s use of Wyeth’s now-withdrawn diet drug Redux caused her death from primary pulmonary hypertension. Id. at *1. Plaintiff’s central claim was that it was unreasonable for Wyeth to market Redux or fail to remove it from the market sooner given the product’s risk profile. Id. at *2. The trial court granted Wyeth’s motion for summary judgment, holding that plaintiff could not bring negligent design defect claims over a drug that had been properly tested, labeled and approved by the Food and Drug Administration (FDA). Id. at *3. On appeal, a three-judge panel of the Superior Court affirmed dismissal of plaintiff’s claims that the manufacturer was negligent in marketing the drug and in its failure to take the drug off the market, but concluded that she could bring a claim of negligent design defect. Id. at *3-4.
On appeal to the Pennsylvania Supreme Court, Wyeth argued that Pennsylvania law did not recognize negligent design claims. Id. at *5-7. Wyeth also maintained that the Superior Court should have deferred to FDA’s regulatory authority, noting that FDA had determined that the drug’s benefits outweighed its risks when it approved the drug. Id. at *8. The Supreme Court upheld the Superior Court’s ruling that plaintiff’s negligent design claims could move forward, and reversed the trial court’s findings on the subject of negligent marketing claims. The Court held that drug manufacturers can face liability for “a lack of due care result[ing] in the dissemination of a product which is not apparently useful or desirable, but rather, is effectively useless and dangerous.” Id. at *13. Further, the Court stated that “a manufacturer or supplier has a duty to cease further distribution of a product at such point as it may know, or may reasonably be charged with knowledge that the commodity is too dangerous to be used by anyone.” Id. at *19.
The Lance decision is more limited than it might seem from some of the broad language used. The Court acknowledged that the ability to assert a negligent design claim would be more difficult where a drug “maintained its FDA approval, it remained on the market, and U.S. doctors continued to prescribe it,” id. at *18 n.33, and declined to address that situation. The Court may have been referring to the additional preemption hurdles in such cases and to the United States Supreme Court’s rejection in Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) of “duty not to sell” theories of liability.